(報告様式4) 【16mk0101008h0003】 平成 29 年 5 月 29 日 平成28年度 委託研究開発成果報告書 I. 基本情報 事 業 名: (日本語)医薬品等規制調和・評価研究事業 (英 語)Research on Regulatory Harmonization and Evaluation of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics 研究開発課題名: (日本語)東アジア地域での薬剤応答性における民族差と国際共同治験や医薬品使用 の実態に関する調査研究 (英 語)Research on the ethnic difference of drug responses, and the survey of the global clinical trials and clinical drug use in East Asian region. 研究開発担当者 (日本語)名古屋市立大学大学院薬学研究科 教授 頭金 正博 所属 役職 氏名: (英 語)Graduate School of Pharmaceutical Sciences, Nagoya City University, Professor, Masahiro Tohkin 実 施 期 間: 平成 28 年 4 月 1 日 ~ 平成 29 年 3 月 31 日 分担研究 (日本語)有害事象自発報告データベースやレセプトデータベース等を用いた副作用 発生率等の比較 開発課題名: (英 語)Comparison of the risk of adverse drug reactions by analyzing data of the adverse drug reaction reporting system and claim data base. 研究開発分担者 (日本語)名古屋市立大学大学院薬学研究科 教授 頭金 正博 所属 役職 氏名: (英 語)Graduate School of Pharmaceutical Sciences, Nagoya City University, Professor, Masahiro Tohkin 分担研究 (日本語)リウマチ性疾患治療薬の使用実態調査と有効性および副作用の個体差・民 族差を規定する要因に関する研究 開発課題名: (英 語)Ethnic factors affecting the clinical drug use and dosage of anti- rheumatoid arthritis drug. 研究開発分担者 (日本語)東邦大学医学部内科学講座膠原病学分野 教授 川合 眞一 所属 役職 氏名: (英 語)Toho University School of Medicine, Division of Rheumatology, Department of Internal Medicine, Professor, Shinichi Kawai 1
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h26_012_1 29 5 29
I.
Research on Regulatory Harmonization and Evaluation of
Pharmaceuticals,
Medical Devices, Regenerative and Cellular Therapy Products, Gene
Therapy
Products, and Cosmetics
Research on the ethnic difference of drug responses, and the survey
of the global
clinical trials and clinical drug use in East Asian region.
Graduate School of Pharmaceutical Sciences, Nagoya City University,
Professor,
Masahiro Tohkin
28 4 1 29 3 31
Comparison of the risk of adverse drug reactions by analyzing data
of the adverse
drug reaction reporting system and claim data base.
Graduate School of Pharmaceutical Sciences, Nagoya City University,
Professor,
Masahiro Tohkin
Ethnic factors affecting the clinical drug use and dosage of anti-
rheumatoid
arthritis drug.
Toho University School of Medicine, Division of Rheumatology,
Department of
Internal Medicine, Professor, Shinichi Kawai
1
A survey of commonly prescribed drugs in East Asia.
Oita University, Faculty of Medicine, Professor, Kyoichi
Ohashi
Precision Medicine Initiative
Consideration of ethnic factors based on the Precision Medicine
Initiative.
School of Pharmacy, Kitasato University, Department of Clinical
Medicine,
Professor, Masahiro Takeuchi
Comparison of the contents (pharmacokinetics and pharmacodynamics)
in the
package inserts of East Asian countries.
Hamamatsu University School of Medicine, Clinical Pharmacology
and
Therapeutics, Professor, Hiroshi Watanabe
Survey on Multi Regional Clinical trials and general situation of
pharmacotherapy
in East Asia
Clinical Research Center, Kitasato University School of Medicine,
Professor,
Yuji Kumagai
Comparison of pharmacokinetics among East Asian populations based
on the
population pharmacokinetics analysis.
Laboratory of Clinical Pharmacokinetics, School of Pharmacy,
Nihon University, Professor, Yoshiaki Matsumoto
New drug development strategies and the study design of the global
clinical trials.
()
Pharmaceuticals and Medical Devices Agency, Chief, Yoshiaki
Uyama
2
2
FAERS
6 11 (1 )(1 )
3
Survey on the global clinical trials and the clinical usage of drug
in East Asia. Survey on the performance of global clinical trials
in East Asia.
Since we noticed remarkable situations of advanced efforts in
Korea, a survey on the performance of clinical researches in Korea
was done. Operational process is very efficient and rapid in Korea
utilizing electronic CRF system. Surprisingly, site management
organization, which is popular in Japan, is not needed at all
because of abundant human resources in their own institution. New
drug development strategies and the study design of the global
clinical trials.
Multi-regional clinical trialsMRCTs have increased year by year,
with the trend of increase of Asian MRCTs. Asian MRCTs should be
considered especially in case large impacts of ethnic factors on
drug efficacy and safety are expected. For the consideration of
ethnic and regional differences, we proposed a new consistency
evaluation index based on Efron's Empirical Bayesian model for the
two sample tests when all the regions are combined. Ethnic factors
affecting the clinical drug use and dosage in East Asia.
The response and tolerability to methotrexate (MTX) is known to
vary among patients and ethnics. We investigated the intracellular
concentrations of MTX polyglutamates (MTXPGs) in patients with
rheumatoid arthritis (RA) under low-dose pulse MTX therapy. Three
polymorphisms of folylpolyglutamate synthase (FPGS) gene
significantly influenced the MTXPG3-5/1-2 ratio in RBCs, while
those of other transporter and enzymes related to MTX intracellular
metabolism had no impact. Differences in allele frequencies of FPGS
between our Japanese patients and a Caucasian population may
suggest the significant differences in tolerable doses to MTX
between the different ethnic cohorts.
Comparison of the pharmacokinetics and the safety among
populations. Comparison of the risk of adverse drug reactions by
analyzing data of the adverse drug reaction reporting
system and claim data base. We compared the adverse drug reaction
(ADR) risk of direct oral anti-coagulant (DOAC), isoniazid, and
tyrosine kinase inhibitors anti-cancer drugs, between Asia and
non-Asia region by analyzing the FDA adverse drug event reporting
system (FAERS). The results suggested that DOAC and isoniazid, but
not tyrosine kinase inhibitors, showed the regional difference of
ADR risk. These results indicated that FAERS is useful to compare
the regional difference of ADR. Comparison of pharmacokinetics
among East Asian populations based on the population
pharmacokinetics
analysis. We studied key factors including ethnicity impacting on
the pharmacokinetics of moxifloxacin, simvastatin and
meloxicam among Japanese, Chinese, Korean, and Caucasian
populations. As covariates, GFR and Korean population on renal
clearance, Korean population on non-renal clearance, lean body mass
and Korean population on volume of distribution for moxifloxacin,
AGE on volume of distribution for simvastatin acid, CYP2C9 genotype
on clearance for meloxicam were identified based on population
pharmacokinetic models. Comparison of the contents
(pharmacokinetics and pharmacodynamics) in the package inserts of
East Asian
countries. We compared the pharmacokinetics and pharmacodynamics of
cardiovascular drug (6 drugs), anti-cancer drugs (11 drugs), anti-
rheumatoid drug, and anti-platelet drug based on the information
from package inserts. The results indicated the ethnic difference
in the dose and the usage, pharmacokinetics, efficacy, and the
frequencies of adverse drug reactions. From these results, we
speculated the disease-related patient’s background and the
criteria of ADR as the consideration points for the global clinical
trials in East Asia. Comparison of the frequency of
genome-biomarker affecting the pharmacokinetics and safety among
East
Asian populations. We evaluated the allele frequencies of 23
genome-biomarkers for the drug response in East Asian populations.
The result suggested that eight kinds of genome-biomarkers showed
ethnic difference in East Asian populations, indicating that these
eight biomarkers are important for the planning the global clinical
trials in East Asia.
4
III.
1. Takeuchi T, Kawai S, Yamamoto K, Harigai M, Ishida K, Miyasaka
N. Post-marketing surveillance of the safety and effectiveness of
tacrolimus in 3,267 Japanese patients with rheumatoid arthritis.
Mod Rheumatol. 2014, 24(1):8-16.
2. Hirayama A, Tanahashi N, Daida H, Ishiguro N, Chachin M, Sugioka
T, Kawai S; on behalf of all ACCEPT study investigators in Japan.
Assessing the cardiovascular risk between celecoxib and
nonselective nonsteroidal antiinflammatory drugs in patients with
rheumatoid arthritis and osteoarthritis: a 3-year nationwide
comparative observational study in Japan (ACCEPT). Circ J. 2014,
78(1):194-205.
3. Kusunoki N, Kojima F, Kawai S. Effects of adipokines on
prostaglandin E2 production by rheumatoid synovial fibroblasts. In:
O’Keefe JM (Ed) Arachidonic Acid: Sources, Biosynthesis and Health
Effects., pp 165-183, Nova Science Publishers, Inc., New York,
2014. [ISBN: 978-1-63117-619-7] [ISBN: 978-1-63117-620-3
(eBook)]
4. Yamamoto T, Hasunuma T, Takagi K, Akimoto K, Shikano K, Kaburaki
M, Muraoka S, Kitahara K, Tanaka N, Kaneko K, Kusunoki Y, Endo H,
Kawai S. A feasibility study assessing tolerability of daily versus
twice weekly trimethoprim-sulfamethoxazole regimen for prophylaxis
against Pneumocystis pneumonia in patients with systemic autoimmune
diseases on glucocorticoid therapy. Jpn J Clin Pharmacol Ther.
2014, 45(3):89-92.
5. Sugiyama A, Hashimoto H, Nakayama Y, Fujita T, Kumagai Y: QT/QTc
study conducted in Japanese adult healthy subjects: a novel
xanthine oxidase inhibitor topiroxostat was not associated with QT
prolongation., J Clin Pharmacol, 2014, 54(4):446-452.
6. Ueno, T., Asahina, Y., Tanaka, A., Yamada, H., Nakamura, M. and
Uyama, Y. Significant differences in drug-lag in clinical
development among various strategies used for regulatory
submissions in Japan. Clin Pharmacol Ther 2014, 95(5):
533-541.
7. Uno, H., Claggett, B., Tian, L., Inoue, E., Gallo, P., Miyata,
T., Schrag, D., Takeuchi, M., Uyama, Y., Zhao, L., Skali, H.,
Solomon, S., Jacobus, S., Hughes, M., Packer, M. and Wei, L.-J.
Moving Beyond the Hazard Ratio in Quantifying the Between-Group
Difference in Survival Analysis. J Clin Oncol, 2014, 32(22):
2380-2385.
8. Uyama, Y., Yamazaki, E., Clark, K., Wang, C. Y., Woro, E., Tong,
F. Y., Sachidanandan, S., Rodriguez, A., Oh, H., Saleh, K.,
Cirunay, J., Wapeewuttikorn, A., Rogov, E., Alshahwan, K. W.,
Herrera, I., Mthetwa, J., Fakudze, F. and Osawa, T. General
Principles for the Education and Training of GCP Inspectors: The
Outcome of Discussions by International Regulatory Experts in the
Discussion Group on ICH E6 guideline. Therapeutic Innovation &
Regulatory Science 2014, 49(2): 249-253.
9. Takeuchi T, Miyasaka N, Kawai S, Sugiyama N, Yuasa H, Yamashita
N, Sugiyama N, Wagerle LC, Vlahos B, Wajdula J. Pharmacokinetics,
efficacy and safety profiles of etanercept monotherapy in Japanese
patients with rheumatoid arthritis: review of seven clinical
trials. Mod Rheumatol. 2015, 25(2):173-186.
10. Ogata A, Amano K, Dobashi H, Inoo M, Ishii T, Kasama T, Kawai
S, Kawakami A, Koike T, Miyahara H, Miyamoto T, Munakata Y,
Murasawa A, Nishimoto N, Ogawa N, Ojima T, Sano H, Shi K, Shono E,
Suematsu E, Takahashi H, Tanaka Y, Tsukamoto H, Nomura A;
5
MUSASHI Study Investigators. Longterm safety and efficacy of
subcutaneous tocilizumab monotherapy: results from the 2-year
open-label extension of the MUSASHI study. J Rheumatol. 2015,
42(5): 799-809.
11. Tanaka, A., Asano, K. and Uyama, Y. How should
ethnicity-related information be included on drug label?:
Considerations based on comparison of MRCT data on the label
between Japan and US. Clin Pharmacol Ther 2015, 98(5):
480-482.
12. Joel Morganroth, Yaning Wang, Michael Thorn, Yuji Kumagai,
Stuart Harris, Noman Stockbridge, Robert Kleiman, Rashmi Shah:
Moxifloxacin-induced QTc interval prolongations in healthy male
Japanese and Caucasian volunteers: a direct comparison in a
thorough QT study, Br J Clin Pharmacol, 2015, 80(3):446-59.
13. Shikano K, Kaneko K, Kawazoe M, Kaburaki M, Hasunuma T, Kawai
S. Efficacy of vitamin K2 for glucocorticoid-induced osteoporosis
in patients with systemic autoimmune diseases. Intern Med. 2016,
55(15):1997-2003.
14. Hasunuma T, Tohkin M, Kaniwa N, Jang IJ, Cui Y, Kaneko M, Saito
Y, Takeuchi M, Watanabe H, Yamazoe Y, Uyama Y, Kawai S. Absence of
ethnic differences in the pharmacokinetics of moxifloxacin,
simvastatin, and meloxicam among three east Asian populations and
Caucasians. Br J Clin Pharmacol. 2016, 81(6):1078-1090.
15. Tanaka N, Masuoka S, Kusunoki N, Nanki T, Kawai S. Serum
resistin level and progression of atherosclerosis during
glucocorticoid therapy for systemic autoimmune diseases.
Metabolites. 2016, Sep 16; 6(3). pii: E28. (doi:
10.3390/metabo6030028)
16. Yamamoto T, Shikano K, Nanki T, Kawai S. Folylpolyglutamate
synthase is a major determinant of intracellular methotrexate
polyglutamates in patients with rheumatoid arthritis. Sci Rep.
2016, 6:35615.
17. Fujio N, Masuoka S, Shikano K, Kusunoki N, Nanki T, Kawai S.
Apparent hypothalamic-pituitary-adrenal axis suppression via
reduction of interleukin-6 by glucocorticoid therapy in systemic
autoimmune diseases. PLoS ONE. 2016, 11(12): e0167854.
18. 2016, 17(4), 411-416. 19. Tanemura, N., Uyama, Y., Nagashima,
K., Suzuki, T., Asahina, Y., Kobayashi, Y., Iyo, M.,
Yokote, K., and Hanaoka, H. Comparison of drug use in older
patients with disease of rheumatoid arthritis, diabetes, high blood
pressure or depression between clinical practice and regulatory
approval in Japan. Therapeutic Innovation & Regulatory Science
2016, 50(6): 743-750.
20. LUO J, IMAI H, OHYAMA T, HASHIMOTO S, HASUNUMA T, INOUE Y,
KOTEGAWA T, OHASHI K, UEMURA N. The Pharmacokinetic Exposure to
Fexofenadine is Volume-Dependently Reduced in Healthy Subjects
Following Oral Administration With Apple Juice. Clin Transl Sci.
2016, 9, 201-6.
21.
(Folia Pharmacol. Jan.) 2016, 148(1), 18-21. 22. Shindo E, Nanki T,
Kusunoki N, Shikano K, Kawazoe M, Sato H, Kaneko K, Muraoka
S,
Kaburaki M, Akasaka Y, Shimada H, Hasunuma T, Kawai S. The growth
factor midkine may play a pathophysiological role in rheumatoid
arthritis. Mod Rheumatol. 2017,
6
27(1):54-59. 23. Miyamoto A, Aoyama T, and Matsumoto Y The
measurement of meloxicam and meloxicam
metabolites in rat plasma using a high-performance liquid
chromatography-ultraviolet spectrophotometry method Chem Pham Bull,
2017, 65, 2, 121-126.
24. :
. . 2017, 7: 61-69. 25. Nanki T, Imai T, Kawai S.
Fractalkine/CX3CL1 in rheumatoid arthritis. Mod Rheumatol.
2017, in press 26. Miyabe C, Miyabe Y, Komiya T, Shioya H, Miura
NN, Takahashi K, Ohno N, Tsuboi R,
Luster AD, Kawai S, Miyasaka N, Nanki T. A sphingosine 1-phosphate
receptor agonist ameliorates animal model of vasculitis. Inflamm.
Res. 2017, in press
27. Hattori, Y, Hanaoka, H, Uyama, Y. Clarifying the Discussion
Points in New Drug Application Reviews for Approval in Japan by a
Government Advisory Council. Therapeutic Innovation &
Regulatory Science 2017, in press
28. Ito Y, Ambe K, Kobayashi M, Tohkin M. Ethnic difference in the
pharmacodynamics-efficacy relationship of dipeptidyl peptidase-4
inhibitors between Japanese and non-Japanese patients: A Systematic
Review. Clin Pharmacol Ther. 2017, in press
1. DMARDs 58 2014
4 24-26 2. Gamma-glutamyl hydrolase gene polymorphisms provide for
intracellular methotrexate
concentration on patients with rheumatoid arthritis, , Kawai S,
Yamamoto T, WCP201417th World Congress of Basic & Clinical
Pharmacology. July 13-18, 2014, Cape Town, South Africa().
3. Significance of serum sRANKL and osteoprotegerin concentration
in patients with rheumatoid arthriti, , Shikano K, Kaneko K,
Kawazoe M, Masuoka S, Sato H, Shindo E, Fujio N, Kaburaki M,
Muraoka S, Tanaka N, Yamamoto T, Takagi K, Kusunoki N, Hasunuma T,
Kawai S. 2014 ACR/ARHP Annual Meeting, Nov 14-19, 2014, Boston,
USA( ).
4. Significance of serum marker levels of Wnt/β-catenin signaling
pathway in patients with systemic autoimmune diseases under
glucocorticoid therapy: a prospective study, , Kawazoe M, Shikano
K, Kaneko K, Masuoka S, Sato H, Shindo E, Fujio N, Muraoka S,
Kaburaki M, Tanaka N, Yamamoto T, Takagi K, Kusunoki N, Hasunuma T,
Kawai S. 2014 ACR/ARHP Annual Meeting. (PO-233) Nov 14-19, 2014,
Boston, USA.
5. Midkine, a growth factor, may play a pathophysiological role in
patients with rheumatoid arthritis, , Shindo E, Hasunuma T, Masuoka
S,Kawazoe M, Sato H, Fujio N, Shikano K, Kaburaki M, Muraoka S,
Tanaka N, Kaneko K, Yamamoto T, Takagi K, Kusunoki N, Kawai S. 2014
ACR/ARHP Annual Meeting. Nov 14-19, 2014, Boston, USA( ).
6. Changes in serum soluble RANKL and osteoprotegerin levels after
teriparatide 7
administration in rheumatic disease patients with
glucocorticoid-induced osteoporosis
, Kaburaki M, Kaneko K, Shikano K, Kawazoe M, Shindo E, Sato H,
Hasunuma T, Fujio N, Muraoka S, Tanaka N, Yamamoto T, Kusunoki N,
Kawai S, Masuoka S. 2014 ACR/ARHP Annual Meeting. Nov 14-19, 2014,
Boston, USA().
7. Regulatory perspective on use of foreign clinical data for drug
approval: PMDA’s experience, , Uyama Y, 5th FIP Pharmaceutical
Science World Congress, 2014/4/16, .
8. Regulatory perspective on use of foreign clinical data for drug
approval: PMDA’s experience, , Uyama Y, APEC MRCT/GCP inspection
workshop, 2014/5/9, .
9. Progress and Challenges to approve a drug based on data from
global clinical trials: PMDA’s experience, , Uyama Y, 50th Annual
DIA meeting, 2014/6/19, .
10. Pharmacogenomics and Regulatory Science, , Uyama Y, Global
Summit on Regulatory Science 2014, 2014/8/21, .
11. Advancing Roles of Japan on Global Drug Development; Ethnic
factors consideration with a view to International Harmonization, ,
Uyama Y, 11th Annual Meeting DIA Japan, 2014/11/18, .
12. Role of Academia and Its Networks for Asian Collaboration in
Clinical Trials, Yuji Kumagai, 8th DIA Annual Conference in Japan
for Asian New Drug Development, 2014.5.22, Tokyo()
13. -ARO -, 32
,2014.11.20,() 14. ,PMDA
2014.12.15,
15. (FAERS)
22
2014 6 28 29 () 16. FAERS
24
2014 9 27 28
17.
242014 9 27 28 18. ETHNIC DIFFERENCE IN ISONIAZID-INDUCED LIVER
INJURY; DETECTION BY
THE FDA ADVERSE EVENT REPORTING SYSTEM DATABASE Nakano S, Kawai K,
Ogawa Y, Tohkin M, 19th North American ISSX Meeting and 29th JSSX
Annual Meeting Oct19 – 23 2014 (San Francisco, USA)
19. EFFECT OF ETHNIC DIFFERENCE OF PHARMACOKINETICS ON THE
PRESCRIPTION DOSE OF STATINS AND SELECTIVE SEROTONIN REUPTAKE
INHIBITORS, , Yamada K, Ito M, Fujiwara Y, Hagiwara H, Kawai S,
Tohkin M, 19th North American ISSX Meeting and 29th JSSX Annual
Meeting Oct19 – 23 2014 (San Francisco, USA)
20. GENETIC VARIATIONS IN ABCB1 INFLUENCE PHARMACOKINETIC
PARAMETERS OF SIMVASTATIN, , Osabe M, Okada Y, Shibakita K, Yamada
R, Kawai S, Tohkin M, 19th North American ISSX Meeting and 29th
JSSX Annual Meeting Oct19 – 23 2014
8
(San Francisco, USA) 21. International Comparison of Suspect Drugs
for Severe Cutaneous Adverse Reactions Using
Adverse Event Reporting System Databases, , Sai K, Segawa K, Tohkin
M, Saito M, Saito Y, 2014 AAPS Annual Meeting and Exposition 2014
11 26 San Diego
22.
23.
35 2014124()
24. Regulatory Science plays an important role in the global
development of new drugs, ,
88 2015 3
25. 112 2015 4 10-12
26. ABC 59
2015 4 23-25 27. Resistin directly stimulates chemokine gene
expressions in rheumatoid synovial fibroblasts:
DNA microarray analysis, Sato H, Muraoka S, Kusunoki N, Kawazoe M,
Masuoka S, Shindo E, Fujio N, Shikano K, Kaburaki M, Tanaka N,
Kaneko K, Yamamoto T, Hasunuma T, Kawai S. EULAR 2015. 10-13 June
2015, Rome, Italy().
28. Suppression of adrenal function is obvious when compared to
that of pituitary function in patients with systemic autoimmune
diseases after glucocorticoid therapy, Fujio N, Muraoka S, Shikano
K, Kaburaki M, Kawazoe M, Shindo E, Sato H, Masuoka S, Tanaka N,
Kaneko K, Yamamoto T, Kusunoki N, Hasunuma T, Kawai S. EULAR 2015.
10-13 June 2015, Rome, Italy().
29. 36 2015 7 22
30. Low molecular weight immunosuppressant therapy of autoimmune
diseases, , Kawai
S, 12th World Congress on Inflammation. (Symposium 24:Biological
and Non-Biological Therapies of Autoimmune Diseases) Aug 8-12,
2015, Boston, USA().
31. CYP2C9 /
2015/ 23 2015/7/4,
32. General principles on planning/designing Multi-Regional
Clinical Trials E17, , Uyama,
Y, DIA workshop: Information Day on ICH, 2015/4/13, . 33. General
principles on planning/designing Multi-Regional Clinical Trials
E17, , Uyama,
Y,7th DIA China annual meeting, 2015/5/26, . 34. Recent efforts to
promote drug development based on MRCTs in Japan, , Uyama Y,
51st Annual DIA meeting, 2015/6/17, . 35. Promoting Multi-Regional
Clinical Trials (MRCTs) with ICH E17 guideline, , Uyama, Y,
ICH E17 Scientific and Regulatory Workshop, 2015/10/26, . 9
36. Regulatory perspective on future drug development with global
collaboration and harmonization, , Uyama, Y, KoNECT International
Conference 2015, 2015/11/4, ().
37. Current and Future Cardiac Safety in Clinical Trials, Yuji
Kumagai, KoNECT International Conference 2015, 2015.11.5,
Seoul
38. , 36
,2015.12.9,
39. Accelerating Asia clinical development through Korea-Japan
collaboration, Yuji Kumagai, Clinical Trial Networking meeting at
DIA Conference, 2015.6.16, Washington DC, USA
40. Effect of apple juice volume on the pharmacokinetics of
fexofenadine in humans, , LUO J,
IMAI H, HASHIMOTO S, HASUNUMA T, OHASHI K, UEMURA N, 36
, 2015/12/9-11,
1
2015 9 12 42.
1 2015 9 12
43. (FAERS)
36
2015 12 9 11 44. 4DPP-4
36 2015 12 9 11 45. 89
/2016 3 9-11 . 46. 89
2016 3 9-11 . 47. , , 60
2016 4 21-23 48. 37
2016 12 1-3 49. 5’- hydroxymethyl 5’- carboxy
136 2016/3/27,
50. 136
2016/3/27, 51. , , , 6DIA
, 2016/2/10, . 52. Efficient assessment of impacts of ethnic
factors on drug responses and recent efforts in Japan for
promoting drug development, , Uyama Y, 52nd Annual DIA meeting,
2016/6/27, . 10
53. Overview of ICH E17 guideline: Importance of international
harmonized guideline focusing on MRCT,
Uyama Y, Quantitative Science Forum, 2016/8/15, .
54. FAERS
20169()
37
2016 12 1 12 3 56. Na+ 2SGLT2
37 2016 12 1
12 3
57. PMDA , , , 34
, 2016/11/4, .
58. Overview of ICH E17, , Uyama Y, ICH/DIA joint workshop,
2016/11/12, .
59. PMDA’s perspective on regulatory science in pharmaceutical
regulation, , Uyama Y, Annual
Conference of the Copenhagen Center for Regulatory Science,
2016/11/24, .
60. , , , 2016, 2016/12/7,
.
61. Strategy for efficient drug development utilizing functions of
RO, , Yuji Kumagai, JSCPT-KSCPT Joint Symposium 2016, 2016.11.18,
Jeonju,Korea
62. ,
, ,, , , , 37 , 2016/12/2, ().
63. ,
2017,2017.2.4, 64. Similarity among East Asians on genetic factors
and several examples on drug efficacy, ,
Yoshiro Saito, 5 -, 2017.2.11, . 65. ,
, , , , , 137 , 2017/3/25, . 66. ,
, , , , , , , ,
, 137, 2017/3/25, (). 67. ,
, , , , , 137 , 2017/3/25, ( ). 68. East Asian regional clinical
trial plays the important role in the new drug development,
Tohkin
M, The 5th Annual Seoul-Kitasato Joint Symposium 2017 2 11
1. Scientific insights about ethnic factors. Sai K, Saito Y.
PMDA-ATC MRCT Seminar 2017 (APEC
Center of Excellence Workshop), 2017/1/20, . 2. Consideration
points on ethnic factors, Tohkin M, 2014 APEC LSIF Joint
Multi-Regional
11
(Qingdao, China),
28
Research on Regulatory Science of Pharmaceuticals and Medical
Devices
Ethnic differences in drug-responses and status of clinical
trials/drug utilization among East Asian countries
National Institute of Health Sciences, Director of Division of
Medicinal
Safety Science, Yoshiro Saito
28 4 1 29 3 31
Comparison of description (pharmacokinetics, efficacy/adverse
reactions) of drug labels among East Asian countries
National Institute of Health Sciences, Director of Division of
Medicinal
Safety Science, Yoshiro Saito
II.
III.
1. :
. . 2017, 7: 61-69. 13
1. Similarity among East Asians on genetic factors and several
examples on drug efficacy, ,
Yoshiro Saito, 5 -, 2017.2.11, 2. ,
, , , , , 137 , 2017/3/25,
1. Scientific insights about ethnic factors. Sai K, Saito Y.
PMDA-ATC MRCT Seminar 2017 (APEC
Center of Excellence Workshop), 2017/1/20, .
28
Research on Regulatory Science of Pharmaceuticals and Medical
Devices
Investigation on ethnic differences in drug responses and actual
conditions of
global clinical trials and drug utilization among East Asian
countries
Division of Medicinal Safety Science, National Institute of Health
Sciences, Section Chief, Kimie Sai
28 4 1 29 3 31
Comparison of allele frequencies of genomic biomarkers associated
with
pharmacokinetics and drug safety among East-Asians
Division of Medicinal Safety Science, National Institute of Health
Sciences, Section Chief, Kimie Sai
II.